Sciatica, Back Pain
Conditions
Brief summary
The study aims at assessing the short and long-term effectiveness and patient perception of benefit with the use of a DIAM™ Spinal Stabilization System in the treatment of complex disc disease at a single level from L2 to L5.
Detailed description
This study is a multi-center, prospective, randomized, controlled trial. Patients will be randomized in 2 groups: Investigational group: a single level herniectomy procedure, followed by placement of the DIAMTM Spinal Stabilization System; Control group: a single level herniectomy procedure; After surgery, patients will be followed for a 2 years period with required follow up visits at 6 weeks, 3 months, 6 months, 1 year, 2 years and 4 years (optional visit).
Interventions
The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach.
PROCEDUREHerniectomy
Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments.
Sponsors
Medtronic Spinal and Biologics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Has a history of sciatica (radicular pain) for at least 6 weeks, but not more than 1 year secondary to one symptomatic lumbar disc herniation at the levels L2-L5 as confirmed by patient history and clinical evaluation, and without major neurological impairment (i.e. not less than M 3/5; Medical Research Council Classification); * Has a history of continuous low back pain for no more than 1 year secondary to lumbar degenerative disc disease (intermittent back pain may occur for more than a year); * Has pre-treatment back pain score greater than or equal to 3, concomitant with leg pain score greater than or equal to 6. Leg pain score must be greater than back pain score (pain intensity score measured on a 10 cm VAS scale); * Has one symptomatic disc herniation: protrusion, extrusion or sequestration (Milette & Fardon, 2001) as confirmed by MRI at the target level; * Evidence of disc degeneration ≤ Grade IV at the target and adjacent levels as confirmed by MRI (Pfirrmann, 2001); * Has an Oswestry Disability Index (ODI) score ≥ 34%; * Has been treated non-operatively (e.g. bed rest, physical therapy, medications, TENS, manipulation, hydrotherapy, acupressure/acupuncture, massage, bracing and/or spinal injections) for at least 6 continuous weeks unless strong clinical grounds for expediting surgery; * Patient male or female, age 20-60 years inclusive and is skeletally mature; * Is willing and able to comply with the study plan and able to provide an informed consent;
Exclusion criteria
* Has a primary diagnosis of spinal disorder other than degenerative disc at the involved level; * Has a symptomatic disc herniation at more than one lumbar level; * Requires a herniectomy at more than one lumbar level; * Has a disc degeneration at the treated and adjacent levels \> Grade IV (Pfirrmann, 2001); * Has a decrease of disc height ≥ 30% as measured by the center of the disc space, and compared to the disc space at the next superior spinal level; * Has Modic changes on MRI greater than Grade I at the target level; * Has Modic changes on MRI at the adjacent levels; * Has an advanced degree of retrolisthesis as shown by lateral X-rays (\> 25%, i.e. grade I as per Meyerding); * Has a clinical evidence of lysis, antero listhesis or scoliosis (Cobb angle more than 10°); * Has signs of segmental instability: more than 4 mm of translation or more than 10° angular motion between adjacent end plates (comparing flexion and extension views); * Has congenital or iatrogenic posterior element insufficiency (e.g. facet resection, spondylolysis, pars fracture, or Spinal Bifida Occulta); * Has had any previous lumbar spine surgery; * Has a Waddell signs of inorganic behaviour score greater than or equal to 3; * Has evidence of an active disruptive psychiatric disorder, cognitive impairment or other known condition, significant enough to impact the perception of pain, precludes surgical procedure, clinical evaluation and/or ability to evaluate treatment outcome as determined by investigator; * Has a known allergy to silicone, polyethylene, or titanium; * Is an alcohol and /or drug abuser, as defined by currently undergoing treatment for alcohol and/or drug abuse; * Has obesity defined by BMI greater than or equal to 35; * Inability to complete the questionnaires; * Planned pregnancy during the course of the study; * Previous enrollment into a spine study; * Vulnerable patients or unable to exercise free informed consent;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS). | 6 Months | The endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI). | 12 Months | The endpoint will be the difference between baseline and 12 months of the patient's score on the Oswestry Disability Index (ODI). The ODI is a low back pain disability questionnaire used to measure a patient's permanent functional disability in a scale from 0 to 50 (when all the 10 sections are answered); large ODI scores indicate large disability. |
Countries
Belgium, Czechia, Germany, Italy, Poland, Spain, Switzerland, United Kingdom
Participant flow
Pre-assignment details
A total of 7 patients were enrolled but not randomized: 6 were excluded due to eligibility criteria not met, and 1 was excluded due to non-compliance issue.
Participants by arm
| Arm | Count |
|---|---|
| Investigational Group Single level herniectomy followed by placement of the DIAM™ Spinal Stabilization System
DIAM™ Spinal Stabilization System: The DIAM™ Spinal Stabilization System is a spacer that is inserted between adjoining spinous processes after doing a standard herniectomy procedure using a posterior surgical approach. | 75 |
| Control Group Single level herniectomy
Herniectomy: Herniectomy is defined as the removal of the extruded/protruded/sequestrated disc material. This is done by probing the annulus and disc space and removing all mobile disc fragments. | 71 |
| Total | 146 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 7 | 4 |
| Overall Study | Physician Decision | 2 | 0 |
| Overall Study | Pregnancy | 0 | 2 |
| Overall Study | Protocol Violation | 2 | 3 |
| Overall Study | Withdrawal by Subject | 5 | 4 |
Baseline characteristics
| Characteristic | Investigational Group | Control Group | Total |
|---|---|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 10 | 40.7 years STANDARD_DEVIATION 10.7 | 41.0 years STANDARD_DEVIATION 10.3 |
| Sex: Female, Male Female | 29 Participants | 29 Participants | 58 Participants |
| Sex: Female, Male Male | 46 Participants | 42 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 44 / 73 | 40 / 71 |
| serious Total, serious adverse events | 15 / 73 | 19 / 71 |
Outcome results
Primary
To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS).
The endpoint will be the difference between baseline and 6 months of the patient's back-pain score on a Visual Analogue Scale (VAS). A standardized visual analogue scale (0cm-10cm; with 0cm meaning 'no pain' and 10cm meaning 'worst possible pain') will be used. Large values of the VAS score represent large degree of pain. Large (negative) change in VAS score (6 months - baseline) represents large relief of pain. For treated subjects, all analyses except the safety analyses, Intent-To-Treat population will serve as the primary analysis dataset.
Time frame: 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Group | To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS). | -3.97 units on a scale | Standard Deviation 2.55 |
| Control Group | To Demonstrate a Statistically Significant Difference in the Relief of Back Pain Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 6-month of the Patient's Back-pain Score on a Visual Analogue Scale (VAS). | -3.37 units on a scale | Standard Deviation 3.15 |
Comparison: The null-hypothesis: Ho: Δ VAS DIAM = Δ VAS Control will be tested against the alternative hypothesis:HA: Δ VAS DIAM ≠ Δ VAS Control.Where Δ is the average decrease in VAS score (baseline - 6 months). A minimal sample size of 240 analyzable patients is required to demonstrate with 80% power a difference in back pain reduction that is significant at the 95% level, comparing DIAM and Control groups. 268 patients will be enroll to allow of up to 10% attrition.p-value: 0.22895% CI: [-1.59, 0.38]t-test, 2 sided
Secondary
To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI).
The endpoint will be the difference between baseline and 12 months of the patient's score on the Oswestry Disability Index (ODI). The ODI is a low back pain disability questionnaire used to measure a patient's permanent functional disability in a scale from 0 to 50 (when all the 10 sections are answered); large ODI scores indicate large disability.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Group | To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI). | -38.55 patient's score | Standard Deviation 20.1 |
| Control Group | To Demonstrate a Statistically Significant Difference in the Reduction of Disability Between Both Treatment Groups. The Endpoint Will be the Difference Between Baseline and 12 Months of the Patient's Score on the Oswestry Disability Index (ODI). | -37.19 patient's score | Standard Deviation 22.61 |
Comparison: The null-hypothesis(Ho: Δ ODI DIAM = Δ ODI Control) will be tested against the alternative hypothesis (HA: Δ ODI DIAM ≠ Δ ODI Control). Δ ODI DIAM = average change in the ODI (12 months - baseline) in the DIAM treated patient group and Δ VAS Control =average change in the ODI in the Control group.p-value: 0.71995% CI: [-8.8, 6.08]t-test, 2 sided